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Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions

Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05290948
Enrollment
57
Registered
2022-03-22
Start date
2022-03-12
Completion date
2022-12-01
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema

Brief summary

In this study, which will be performed as a randomized clinical trial, all patients with macular edema with central involvement (central macular thickness greater than 300 μm) and corrected vision less than or equal to 20/40 and better than 20/400 were included in the study. After a thorough eye examination, people are randomly divided into two groups. The first group was treated with intravitreal injection of Bevacizumab in three injections one month apart with receiving oral Acetazolamide tablets of 250 mg twice a day, and the second group was treated with intravitreal injection of Bevacizumab for three Loads are spaced one month apart. Ophthalmologic examinations and corrected visual acuity, as well as macular thickness examination, are repeated with Spectral-domain Optical coherence tomography (SD-OCT) at the beginning of treatment and at the end of the first, second, and third months. At the end of the study, the rate of changes in visual acuity and macular thickness in the eyes in the two groups will be compared and will be statistically analyzed.

Interventions

DRUGintravitreal injection of bevacizumab with acetazolamide tablets

intravitreal injection of bevacizumab with acetazolamide tablets

intravitreal injection of bevacizumab

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 20 / 400≤ Best Corrected Visual Acuity ≤20 / 40 * Central macular thickness \<300 μm * The onset of the disease is less than three years * No other eye diseases that affect the evaluation and process of this study.

Exclusion criteria

* It is not possible to provide informed consent. * Patients who are prohibited from taking oral acetazolamide (renal failure, hepatic failure, history of allergies) * Other eye diseases that affect the evaluation and process of this study. Including diabetes retinopathy * History of retinal laser photocoagulation

Design outcomes

Primary

MeasureTime frameDescription
Best Corrected Visual Acuity3 monthsthe best corrective vision correction that achieved by glasses, as measured on the standard Snellen eye chart

Secondary

MeasureTime frameDescription
Central macular thickness3 monthsThickness measurements by spectral-domain optical coherence tomography systems (SD-OCT)

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026